Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Multi-antibiotic Resistance Clinical Trial

Official title:

Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909946
• Other study ID #: R01AG041780
• Status: Completed
• Phase: N/A
• Start date: September 15, 2016
• Est. completion date: August 29, 2018

Study information

• Verified date: September 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence rates surpassing those in hospitals. The aim of the study is to design and evaluate the effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH residents. The intervention will incorporate resident-level, environmental, and caregiver based strategies. Using a cluster-randomized study design, three NHs will be randomized to the intervention group and three to the control group. Control NHs will be allowed to continue standard infection prevention practices. Nursing homes will serve as the unit of allocation. Analyses will be performed both at the resident and the cluster level. The primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO acquisition .

Description:

The NH intervention will incorporate resident-level, environmental, and caregiver based strategies, including: a. Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for healthcare workers (HCW) when providing activities of daily living (ADL) assistance for residents at highest-risk (caregiver intervention); b. Hand hygiene education to residents and families (resident-level intervention); c. Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention); d. Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention); e. Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection preventionists, front-line healthcare personnel, and facility leadership (facility intervention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: August 29, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Residing in a participating NH facility

• Provided informed consent for participation

Exclusion Criteria:

• Receiving end-of-life care

• Non-English language speaking

Related Conditions & MeSH terms

• Multi-antibiotic Resistance

Intervention

Behavioral:
• Multi-modal Infection Control Program
Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for HCW when providing ADL assistance for residents at highest-risk (caregiver intervention). Hand hygiene education to residents and families (resident-level intervention). Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention). Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention). Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection control practitioners, HCWs, and facility leadership (facility intervention).

Locations

Country	Name	City	State
United States	University of Michigan and partner nursing homes	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence density of multidrug-resistant organisms (MDRO)	Total number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents over the duration of the study period	From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Secondary	Incidence of multidrug-resistant organisms (MDRO)	Total number of MDROs newly acquired (resident not colonized at baseline) isolated across all MDROs for all enrolled residents over the duration of the study period	From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Secondary	Incidence of healthcare-associated infections	Total number of new infections acquired at the nursing home for all enrolled residents over the duration of the study period	From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)